DEVELOPMENT OF AN ANTIGEN CAPTURE ASSAY FOR HTLV-I

PHASE I RESEARCH IILL DEVELOP A PROTOTYPE ELISA ANTIGEN-CAPTURE KIT TO MEASURE HTLV-I CORE PROTEINS P19 AND P24 PRODUCED DURING VIRUS REPLICATION IN CELLS. HTLV-I IS LINKED TO THE DEVELOPMENT OF ADULT T-CELL LEUKEMIA AND TOTROPICAL SPASTIC PARAPARESIS, A NEUROLOGICAL DISEASE OF INTEREST TO RESEARCHERS ON MULTIPLE SCLEROSIS. TRACKING THE PROGRESS OF HTLV-I INFECTION IN TISSUE CULTURES IS MORE DIFFICULT THAN TRACKING HIV INFECTION: HTLV-I SELDOM KILLS THE CELLS IT INFECTS, AND THE REVERSE TRANSCRIPTASE (RT) IT PRODUCES IS NOT VERY ACTIVE IN CURRENT RT ASSAYS. THEREFORE, A COMMERCIAL KIT THAT MEASURES THE CORE PROTEINS PRODUCED DURING INFECTION WILL BEVALUABLE IN STUDIES OF HTLV-I IN TISSUE CULTURE. THE PROTOTYPE ASSAY WILL USE P19 AND P24 ANTIBODIES AS CAPTURE ANTIBODIES. HIGH-TITER HUMAN SERA WILL BE USED AS THE DETECTOR ANTIBODY UNTIL HYPERIMMUNE RABBIT SERA IS AVAILABLE. THE PROTOTYPE ASSAY WILL BE MORE SENSITIVE THAN RT ASSAYS IN TRACKING HTLV-I INFECTION, BUT ITS SENSITIVITY WILL BE LIMITED BY THE CURRENT LACK OF VERY HIGH-AFFINITY MONOCLONAL ANTIBODIES FOR P19 AND P24. PRODUCTION OF HIGH-AFFINITY MONOCLONAL ANTIBODIES WILL BEGIN IN PHASE I.